NCT05488587

Brief Summary

Hepatocellular carcinoma (HCC) is the sixth most frequent malignancy worldwide, with an estimated 906,000 new cases and 830,000 deaths in 2020. It is also the third leading cause for cancer deaths, with 15% 5-year survival rate . Diagnosis of HCC in cirrhotic patients is mainly based on non-invasive imaging techniques. Multiphasic computed tomography (CT) and dynamic contrast-enhanced magnetic resonance imaging (MRI) are the most sensitive imaging techniques for diagnosis of HCC. While the most common serologic marker for early screening of HCC is alpha-fetoprotein (AFP) . Liver is the main site of trace elements metabolism, and their levels are affected by different causes of liver disease .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

July 19, 2022

Last Update Submit

August 6, 2022

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Serum levels of Magnesium in cirrhotic patients and HCC

    To evaluate the serum level of Magnesium in cirrhotic patients with HCC, and to compare it with the level in cirrhotic patients without HCC and in healthy subjects.

    12 months

  • Serum level of Zinc in cirrhotic patients and HCC

    To evaluate the serum level of Zinc in cirrhotic patients with HCC, and to compare it with the level in cirrhotic patients without HCC and in healthy subjects.

    12 months

Secondary Outcomes (2)

  • serum level of Magnesium and the Barcelona clinic classification

    12 months

  • serum level of Zinc and the Barcelona clinic classification

    12 months

Study Arms (3)

hepatocellular carcinoma

Diagnostic Test: magnesium and zinc levels

liver cirrhosis

Diagnostic Test: magnesium and zinc levels

healthy individuals

Diagnostic Test: magnesium and zinc levels

Interventions

magnesium and zinc levelsDIAGNOSTIC_TEST

measuring magnesium and zinc levels

healthy individualshepatocellular carcinomaliver cirrhosis

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults of both genders with compensated or decompensated liver cirrhosis with or without HCC.

You may qualify if:

  • Adults (≥18 years old) of both genders with compensated or decompensated liver cirrhosis with or without HCC.

You may not qualify if:

  • Patients who received Zn or Mg supplementation within the previous 3 months.
  • Non-cirrhotic HCC
  • Patients with other malignancies.
  • Pregnant and lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • Al Alawi AM, Majoni SW, Falhammar H. Magnesium and Human Health: Perspectives and Research Directions. Int J Endocrinol. 2018 Apr 16;2018:9041694. doi: 10.1155/2018/9041694. eCollection 2018.

    PMID: 29849626BACKGROUND

  • Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Pineros M, Znaor A, Bray F. Cancer statistics for the year 2020: An overview. Int J Cancer. 2021 Apr 5. doi: 10.1002/ijc.33588. Online ahead of print.

    PMID: 33818764BACKGROUND

  • Huang WQ, Long WQ, Mo XF, Zhang NQ, Luo H, Lin FY, Huang J, Zhang CX. Direct and indirect associations between dietary magnesium intake and breast cancer risk. Sci Rep. 2019 Apr 8;9(1):5764. doi: 10.1038/s41598-019-42282-y.

    PMID: 30962499BACKGROUND

  • Meng Y, Sun J, Yu J, Wang C, Su J. Dietary Intakes of Calcium, Iron, Magnesium, and Potassium Elements and the Risk of Colorectal Cancer: a Meta-Analysis. Biol Trace Elem Res. 2019 Jun;189(2):325-335. doi: 10.1007/s12011-018-1474-z. Epub 2018 Aug 31.

    PMID: 30171595BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Ahmed A Ibrahim, Residant

CONTACT

01008444278ahmedatef8444@gmail.com

Mahmoud S El-Islam, assitant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Tropical Medicine and Gastroenterology

Study Record Dates

First Submitted

July 19, 2022

First Posted

August 4, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

EG(1)